Should a pharmacist be legally liable for filling valid opioid prescriptions?

Mak Wen Yao , 6 days ago

Doctors and pharmacists are increasingly being held liable for negligence and unscrupulous prescribing and dispensing potent opioid analgesics.

The United States of America has an opioid addiction problem. In fact, it is all too frequent to refer to the widespread misuse of painkillers as the "opioid epidemic". Many reports attributed the problem to aggressive pharmaceutical marketing and unscrupulous prescribing patterns. We have also witnessed an increasing number of doctors being held liable – some even faced murder charges – for the opioid prescriptions they wrote.

As the epidemic has shown no signs of improvement, officials are now considering to extend the legal implications over pharmacists.

The scope of the epidemic

A 2010 report from the US Centres for Disease Control and Prevention (CDC) indicated that, within the same year, doctors in the country wrote enough hydrocodone prescriptions to supply each American adult with a one-month supply of the opioid analgesic.

In addition, a separate study, which zoomed into the pattern of opioid prescription after patients experienced a non-fatal overdose, discovered that almost all these patients continued to receive prescriptions for opioids.

Looking more closely at the prescribing pattern, a huge portion of these prescriptions came from general practitioners, rather than a handful of pain management specialists – indicating that the problem was more pervasive, relatively indifferent to prescribers' speciality and systemic in nature.

Should pharmacists bear equal responsibility?

Given the scope and severity of the opioid epidemic, it is not surprising to see the US enforcement going after pharmacists or pharmacies and hold them legally liable, or even place criminal charges on them, should available evidence supports so.

Dr Keith Yoshizuka, PharmD, JD of Touro University College of Pharmacy, opined that "I don't think it's too large of a leap to expect a pharmacist to face criminal liability in the event that one or several of the patients overdose on medications that were filled by that pharmacy."

For example, in 2015, Manish Patel, a licensed pharmacist and owner of the Daytona Discount Pharmacy was ordered to stand trial for the overdose death of Steven Porter from combined drug intoxication of alprazolam and hydrocodone. Patel was alleged to have filled at least thirty of these prescriptions over a period of two years without question, even though some of the prior prescriptions were not depleted. It is worth noting that all the prescriptions were valid, and Patel filled them in full compliance with the regulations.

The judge initially ruled that Patel owed no duty to the now deceased Porter, other than to fill "valid and lawful prescriptions". However, such ruling was overturned in the subsequent appeal where the judges wrote "A pharmacist's duty to use due and proper care in filling a prescription extends beyond simply following the prescribing physician's direction… . Pharmacists are required to exercise that degree of care that an ordinarily prudent pharmacist would under the same or similar circumstances."

Talking to Medscape Medical News, Dr Yoshizuka said “I can see the district attorney going after that pharmacy or the pharmacist for second-degree murder for, basically, recklessness – criminal negligence. But, demonstrating that liability is still not clear-cut.”

A pharmacist’s obligation: Corresponding responsibility

The issue of whether to dispense a legal opioid prescription to someone who may be an addict, but at the same time has legitimate pain, is very subjective. In fact, the topic is worthy of detailed scrutiny.

In the early 70s, the US Drug Enforcement Administration (DEA) established the doctrine of corresponding responsibility to guide pharmacists in dispensing controlled substances, including opioid analgesics. Nonetheless, as noted by Larry Cote, a DEA compliance attorney, “corresponding responsibility” is one of the most misunderstood or unknown concepts to pharmacists.

All in all, the responsibility to prescribe a controlled substance falls upon the prescribing practitioner, while the corresponding responsibility rests with the pharmacist who fills the prescription. Should the pharmacist knowingly fill a prescription that is "not in the usual course of professional treatment or in legitimate and authorized research" – the pharmacist will be subjected to relevant legal actions.

While the legal battles continue, pharmacist are reminded that, regardless of our geographical boundaries and the legal structure under which we operate – strict compliance with relevant opioid regulations is necessary to insulate us from claims of legal liability. After all, pharmacists are the final gatekeepers who have the control over the flow of these potent medications. MIMS

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